Industry news

• Scientists from Iran, Australia and Russia Developed Hybrid Micromixer

  14 February 2019 GMP News

  An international team of scientists including research associate from Sechenov University developed a device for mixing chemical and biological reaction feeds. The team managed to increase the mixing efficiency up to 90%. The new device will be used in biological and chemical experiments. 

• PhRMA Criticize Damaging Price Control in Some Countries

  14 February 2019 GMP News

  The Pharmaceutical Research and Manufacturers of America (PhRMA) urged the Office of the United States Trade Representative (USTR) to take immediate action to address serious and growing market access and intellectual property barriers in top overseas markets.

• FDA’s Guide on Immunogenicity Testing of Therapeutic Protein Products

  13 February 2019 GMP News

  For the evaluation of pharmacokinetics, pharmacodynamics, efficacy and safety of biological drugs and active substances, possible immunareactions of patients are of decisive importance. Especially in the case of therapeutic protein products, immune reactions, i.e. the formation of so-called anti-drug antibodies (ADAs), can have the potential to negatively influence the therapeutic benefit or completely override it.

• FDA Final Guidance – Warning of Recalls

  13 February 2019 GMP News

  The U.S. Food and Drug Administration (FDA) recently released the final guidance entitled “Public Warning and Notification of Recalls.” The announcement of the guidance has been published in the Federal Register on February 8, 2019.

• New Safety Features for EU Medicine

  13 February 2019 GMP News

  As of 9 February 2019, most prescription medicines and some over-the-counter medicines for human use supplied in the European Union are required to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging. The anti-tampering device is a safety feature that shows whether the packaging has been opened or altered since it left the manufacturer, thereby ensuring that the content of the packaging is authentic.

• EMA Launched Online Platform for Parallel Distribution

  13 February 2019 GMP News

  EMA has launched a secure online platform for submitting and managing parallel distribution notifications through the recently implemented IRIS Regulatory & Scientific Information Management Platform. Starting today, 11 February, parallel distributors are required to use IRIS that was developed in June 2018 for orphan designation applications and will now be gradually rolled out to cover other regulatory and scientific procedures.

• Big Pharma to Testify in High Drug Pricing Case

  12 February 2019 GMP News

  While congressional scrutiny on drug pricing is nothing new, the prospect of some of the pharmaceutical industry’s highest-profile CEOs testifying on the issue will make for a must-watch event.

• Pilot Project for Drug Supply Chain Security Act of FDA

  12 February 2019 GMP News

  A key element of the U.S. Food and Drug Administration’s mission is focused on helping to ensure that all products FDA regulates, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in nation’s drug supply chain.

• Thai Company to Build Factory in Russia

  11 February 2019 GMP News

  The pharmaceutical company Besins Healthcare SA will build an integrated factory in Yaroslavl (250 miles north of Moscow) for producing Utrogestan, a drug to prevent premature births and miscarriages. The company’s representative office in Russia signed an agreement with the Yaroslavl Region government at the end of November. The news was announced by deputy chairman of the regional government Maxim Avdeyev at an itinerant session of the St. Petersburg International Economic Forum “Russian regions: New points of growth,” held in early December.

• Russian Scientists Developed Cancer Drug

  11 February 2019 GMP News

  Russian scientists have developed a new drug for the treatment of cancer, which is comparable to the drug whose creators were awarded the Nobel Prize last year, and its certification is expected to take place in 2019, a Russian researcher told.